Compliance
The OPENGATE device uses low-frequency electro-magnetic technology, dynamic non-contact detection, and meets EMC electromagnetic radiation standards. It does not harm humans, medical devices like pacemakers, pregnant women, kids, or electronic devices.
Test the system with the “Security Standard” of your choice each time it is moved and at least once a month to ensure it is detecting in all 9 areas of the WDS as stated In the best practice guide by Homeland Security.
Test the system after setup with the “Security Standard” of your choice.
Document your settings (“Security Standard”) when changed and who tested the system after it has been changed.
- Document any failed tests and how you fixed them
- Document any parts replaced on the system and when it was fixed and test results afterward.
- Document any findings when in use
- Test the system daily and before any big events to ensure the system is operating as expected.
- Document the “Security Standard” settings you run the system on for the threat level that your organization is currently experiencing.
EN 45502-2-1:2003. (Cardiac pacemakers)
EN 45502-2-2:2008. (Implantable defibrillators)
ISO 14117:2019. (Cardiac pacemakers, cardioverter defibrillators, cardiac resynchronization devices)
ISO 14708-1:2014 (Implants for surgery)
ISO 14708-2:2019 (Cardiac pacemakers)
ISO 14708-3:2017 (Implantable neurostimulators)
ISO 14708-4:2008 (Implantable infusion pumps)
ISO 14708-5:2020 (Circulatory support devices)
ISO 14708-6:2019 (Implantable tachyarrhythmia treatmentdevices))
ISO 14708-7:2019 (Cochlea implants, auditory brainstem implantsystems)
